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FDA Issues Compliance Policy Guide For Food Allergen Labeling

Date: May 01, 2001


FDA's Compliance Policy Guide (CPG) sets policy of labeling and preventing cross-contact of common food allergens. Although FDA issued a letter to food companies in 1996 to increase allergen awareness, the Agency decided further action was needed given the increase in undeclared allergen recalls from 35 per year 10 years ago to 121 in fiscal year 2000.

FDA's policy on allergens is that products that contain an allergenic ingredient by design must - as with most all intentionally added ingredients - be declared on the label. Processing aids that contain allergenic ingredients must also be declared.

Further, although an exemption is in place for specifying the individual ingredients in mixtures of spices, flavors and certain colors added to food, FDA "strongly encourages" listing any allergenic ingredient that is contained in a spice, flavor or color. In this regard, the Agency notes that it is considering creating regulations to require such labeling.

Finally, FDA notes that production practices that lead to the unintentional addition of allergens to food may be considered unsanitary and the food potentially adulterated.

A copy of the CPG is available on the internet at www.fda.gov/ora. Although effective immediately, FDA is accepting comments on the document and will hold a public meeting on August 13, 2001, to discuss the labeling of food allergens.

Used with permission. Copyright FOOD & DRUG PACKAGING, May, 2001.

For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at misko@khlaw.com.